Combined Therapies for Recurrent Brain Cancer
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Monteris Medical
Must not be taking: Bevacizumab
Disqualifiers: More than 3 lesions, Concurrent malignancies, Serious infection, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used bevacizumab within 4 weeks of starting the study. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of this treatment for recurrent brain cancer?
Research shows that radiotherapy, including stereotactic radiosurgery and reirradiation, can improve survival and quality of life for patients with recurrent brain metastases, with minimal side effects. These treatments are effective in controlling local brain disease and are considered safe options for managing relapsing brain conditions.
12345Is the combined therapy for recurrent brain cancer generally safe for humans?
Image-guided radiation therapy (IGRT) and intensity-modulated radiotherapy (IMRT) are generally considered safe, with some risk of side effects like gastrointestinal and genitourinary issues. The safety of these therapies has been a focus of research, and they are commonly used in clinical practice.
36789How is the treatment of radiation therapy unique for recurrent brain cancer?
Radiation therapy for recurrent brain cancer is unique because it uses advanced techniques like stereotactic radiotherapy (SRT) and intensity-modulated radiation therapy (IMRT) to precisely target tumors, minimizing damage to healthy brain tissue. This approach allows for a second course of radiation, which is not standard, offering a potential option for patients with recurrent tumors.
310111213Eligibility Criteria
This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.Inclusion Criteria
I am 18 years old or older.
I've been stable for 3 days on a low steroid dose.
I had my initial SRS treatment for the target lesion over 3 months ago.
+10 more
Exclusion Criteria
My cancer outside the brain is quickly getting worse.
I do not have any serious infections or other major health issues.
Patients unable to comply with study requirements
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or hypofractionated radiation therapy (RT) for recurrent brain metastases
3 months
Multiple visits for treatment and monitoring
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
24 months
Post-op visit, 1 month visit, and subsequent follow-up visits until study exit or 24 months
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Participant Groups
The REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.
2Treatment groups
Experimental Treatment
Group I: Recurrent TumorExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Group II: Radiation NecrosisExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kettering HealthKettering, OH
Cleveland ClinicCleveland, OH
UCLALos Angeles, CA
Medical College of WisconsinMilwaukee, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Monteris MedicalLead Sponsor
References
Radiotherapy and chemotherapy of brain metastases. [2018]The authors have reviewed the results, the indications and the controversies regarding radiotherapy and chemotherapy of patients with newly diagnosed and recurrent brain metastases. Whole-brain radiotherapy, radiosurgery, hypofractionated stereotactic radiotherapy, brachytherapy and chemotherapy are the available options. New radiosensitizers and cytotoxic or cytostatic agents are being investigated. Adjuvant whole brain radiotherapy, either after surgery or radiosurgery, and prophylactic cranial irradiation in small-cell lung cancer are discussed, taking into account local control, survival, and risk of late neurotoxicity. Increasingly, the different treatments are tailored to the different prognostic subgroups, as defined by Radiation Therapy Oncology Group RPA Classes.
Salvage stereotactic radiosurgery for brain metastases. [2013]Recurrent or progressive brain metastases after initial treatment represent a common clinical entity mainly due to increased survival of cancer patients. From the various available treatment modalities, salvage stereotactic radiosurgery seems to be the most commonly used. Many clinical studies of class of evidence III have demonstrated satisfied results concerning the local brain control and survival of patients with relapsing brain disease. Also stereotactic radiosurgery is considered a relatively safe modality with low incidence of brain toxicity side effects. It is obvious that well-designed, randomized, prospective studies are necessary for the evaluation of the stereotactic radiosurgery as salvage treatment and for the establishment of guidelines for the selection of patients most suitable for this treatment option. The increasing number of patients with relapsing brain metastatic disease will act as a pressure to this direction.
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. [2019]To evaluate the toxicity and efficacy of re-irradiation with salvage stereotactic radiotherapy (SRT) for recurrent glioma using CyberKnife.
Improving radiotherapy for brain tumors. [2005]Radiation oncologists treating patients with primary brain tumors are faced with two important issues: How to improve the cure rate over that which is achievable with the current radiotherapy modalities and how to decrease long-term morbidity while maintaining or improving the cure rate. Several new approaches are being studied, including interstitial implants, stereotactic radiosurgery, new radiation modalities, radiosensitizers, hyperthermia, and altered fractionation programs. It is nonetheless important to remember that such innovative radiotherapy must be incorporated into the overall multimodal therapy for patients with primary malignant brain tumors.
Reirradiation for progressive brain metastases. [2022]Brain metastases constitute one of the most common distant metastases of cancer and are increasingly being detected with better diagnostic tools. The standard of care for solitary brain metastases with the primary disease under control is surgery followed by radiotherapy. Radiotherapy is also the primary modality for the treatment of multiple brain metastases, and improves both the quality of life and survival of patient. Unfortunately, more than half of these treated patients eventually progress leading to a therapeutic dilemma. Another course of radiotherapy is a viable but underutilized option. Reirradiation resolves distressing symptoms and has shown to improve survival with minimal late neurotoxicity. Reirradiation has conventionally been done with whole brain radiotherapy, but now studies with stereotactic radiosurgery have also shown promising results. In this review, we focus on reirradiation as a treatment modality in such patients. We performed a literature search in MEDLINE (www.pubmed.org) with key words brain metastases, reirradiation, whole brain radiotherapy, stereotactic radiosurgery, interstial brachytherapy, and brain. The search was limited to the English literature and human subjects.
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial. [2021]Current studies on salvage radiotherapy (sRT) investigate timing, dose-escalation and anti-hormonal treatment (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT. A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated radiotherapy.
A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis. [2022]Reirradiation (re-RT) using external beam radiation therapy (EBRT) is a novel salvage strategy for local failure in prostate cancer. We performed a systematic review describing oncologic and toxicity outcomes for salvage EBRT/stereotactic radiation therapy (SBRT) re-RT.
The evolving role of reirradiation in the management of recurrent brain tumors. [2023]Despite aggressive management consisting of surgery, radiation therapy (RT), and systemic therapy given alone or in combination, a significant proportion of patients with brain tumors will experience tumor recurrence. For these patients, no standard of care exists and management of either primary or metastatic recurrent tumors remains challenging.Advances in imaging and RT technology have enabled more precise tumor localization and dose delivery, leading to a reduction in the volume of health brain tissue exposed to high radiation doses. Radiation techniques have evolved from three-dimensional (3-D) conformal RT to the development of sophisticated techniques, including intensity modulated radiation therapy (IMRT), volumetric arc therapy (VMAT), and stereotactic techniques, either stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT). Several studies have suggested that a second course of RT is a feasible treatment option in patients with a recurrent tumor; however, survival benefit and treatment related toxicity of reirradiation, given alone or in combination with other focal or systemic therapies, remain a controversial issue.We provide a critical overview of the current clinical status and technical challenges of reirradiation in patients with both recurrent primary brain tumors, such as gliomas, ependymomas, medulloblastomas, and meningiomas, and brain metastases. Relevant clinical questions such as the appropriate radiation technique and patient selection, the optimal radiation dose and fractionation, tolerance of the brain to a second course of RT, and the risk of adverse radiation effects have been critically discussed.
Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease. [2020]Due to improvements in systemic therapies and longer survivals, cancer patients frequently present with recurrent brain metastases (BM). The optimal therapeutic strategies for limited brain relapse remain undefined. We analyzed tumor control and survival in patients treated with salvage focal radiotherapy in our center. Thirty-three patients with 112 BM received salvage stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) for local or regional recurrences. Local progression was observed in 11 BM (9.8 %). After 1 year, 72 % of patients were free of distant brain failure, and the 2-year overall survival (OS) was 37.7 %. No increase in toxicity or neurologically related deaths were observed. The 2- and 3-year whole brain radiation therapy free survival (WFS) rates were 92.9 % and 77.4 %, respectively. Hence, focal radiotherapy is a feasible salvage of recurrent BM in selected group of patients with limited brain disease, achieving a maintained intracranial control and less neurological toxicity.
Efficacy of stereotactic radiotherapy as salvage treatment for recurrent malignant gliomas. [2018]To evaluate the efficacy and toxicity of CyberKnife stereotactic radiotherapy (SRT) for recurrent glial tumors previously treated with high-dose radiotherapy.
Salvage Radiation Therapy for Patients With Relapsing Glioblastoma Multiforme and the Role of Slow Fractionation. [2022]Salvage radiation therapy (SRT) can be offered to patients with relapsing glioblastoma multiforme (GBM). Here we report our experience with a schedule extending the treatment time of SRT with the aim to prolong the cytotoxic effect of ionizing radiation while minimizing the cytotoxic hazards for the surrounding brain.